BURINEX Tablet Ref.[2578] Active ingredients: Bumetanide

Bumetanide is nearly totally absorbed from the gastro-intestinal tract. After peroral administration, a bioavailability of between 80‑95% is observed. Diuresis begins within ½‑1 hour with a peak effect between 1 and 2 hours. The diuretic effect lasts up to about 4 hours. Bumetanide is eliminated with half-life ranging from between 1 to 2 hours after oral administration of a dose of 0.5‑2 mg. It is strongly bound to plasma proteins and renal excretion of unchanged drug accounts for about half of the total clearance. The hepatic metabolism and biliary excretion accounts for the other half. The primary metabolites are conjugated alcohols of bumetanide. No active metabolites have been found. Bumetanide has a steep dose response curve.

In neonates and infants, elimination appears slower than in older paediatric patients and adults, possibly because of immature renal and hepatobiliary functions. Mean serum elimination half-life decreases during the first month of life from 6 hours in neonates to 2.4 hours in infants 1 month of age.

Mean serum elimination half-life is 2.5 and 1.5 hours in infants younger than 2 months of age and in those 2–6 months of age, respectively. The apparent elimination half-life may be prolonged to approximately 6 hours (with a range up to 15 hours) after IV administration in premature or full-term neonates with respiratory disorders. Data for younger children, including neonates and infants, is not sufficient to allow for dosing recommendations, see 4.2.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.